Clinical trial Recruiting at 3 sites Interventional Ages 18 to 65

Dietary approach to managing mild-to-moderate psoriasis

Official title: The Role of Gut-skin Axis in Psoriasis: a Randomized Placebo-controlled Dietary Approach to Assess Clinical Efficacy in Mild-to-moderate Psoriasis

Run by University of Palermo · NCT05644782 · Data updated 2026-11-12

This study tests if changing the diet, especially by looking at gluten sensitivity, can help people with mild-to-moderate psoriasis feel better.

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment82 (estimated)
SponsorUniversity of Palermo
Academic / other
Drugs / interventionschemotherapy
Locations3 sites (Palermo, Palermo and 2 other locations)
StatusRecruiting
StartedJanuary 1, 2025
Main results expectedJanuary 1, 2026
Study endsJanuary 1, 2027
Registry record updatedJanuary 12, 2026
Trial IDNCT05644782 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 to 65 with mild-to-moderate psoriasis who have not undergone systemic therapy for at least three months and do not have gluten sensitivity.

Probably not a fit

Patients with severe chronic plaque-type psoriasis, those who have self-excluded gluten from their diet, or individuals with other significant gastrointestinal or inflammatory conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of dietary interventions, specifically focusing on gluten sensitivity, in patients with mild-to-moderate psoriasis. It aims to explore the gut-skin axis and how dietary changes may influence the inflammatory processes associated with psoriasis. Participants will undergo an open wheat challenge and a placebo challenge to assess their reactions and symptoms. The study seeks to understand the potential link between diet and psoriasis severity, particularly in patients who may have gluten sensitivity.

Why it matters

Potential benefit: If successful, this approach could provide a dietary management option for patients with psoriasis, potentially reducing symptoms and improving quality of life.

How similar studies have gone: While dietary approaches in managing psoriasis are being explored, this specific focus on gluten sensitivity and its direct impact on psoriasis is relatively novel and has not been extensively tested in previous studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion criteria of psoriasis patients

* age \>18 and \<65 years;
* no systemic therapy for psoriasis for at least 3 months before inclusion in the study;
* negativity of anti-deamidated gliadin protein (anti-DGP) immunoglobulins (Ig) class A (IgA) and immunoglobulins (Ig)G, anti-tissue transglutaminase (anti-tTG) class IgA and IgG, and Endomysium antibodies (EmA);
* absence of WA (negative prick-test and/or specific serum immunoglobulins (Ig)E assay for wheat, gluten, and gliadin).

Exclusion criteria of psoriasis patients age \<18 and \>65 years;

* severe chronic plaque-type psoriasis (based on BSA);
* self-exclusion of gluten/wheat from the diet and refusal to reintroduce it, for diagnostic purposes, before entering the study;
* pregnancy;
* alcohol and/or drug abuse;
* Helicobacter pylori and other bacterial and/or parasitic infections;
* diagnosis of chronic inflammatory bowel disease and other organic pathology affecting the digestive system (e.g., severe liver disease), nervous system diseases, major psychiatric disorders, immunological deficits, and impairments that limit physical activity;
* diagnosis of cancer
* treatment with steroids and/or immunological therapies;
* patients undergoing chemotherapy and/or radiotherapy.

Where it's running

  • Dermatology Department of the University Hospital 'P. Giaccone' of Palermo, Italy,
    Palermo, Palermo, Italy
    Recruiting
  • Internal Medicine Department of the University Hospital of Palermo
    Palermo, Palermo, Italy
    Recruiting
  • Internal Medicine Division of the "Cervello-Villa Sofia" Hospital
    Palermo, PA, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.